GP surgeries audit raises vaccine fears

A SAFETY audit of every GP surgery in Scotland has revealed that hundreds of family doctors have wrongly stored vaccines used to protect children and adults against life-threatening diseases, raising fears about the effectiveness of some jabs.

The study states that 148 surgeries failed to keep to the vaccine makers' storage guidelines and says that "inappropriate vaccine storage is very serious and has the potential to present a public heath problem".

The Scottish Government Health Department report says that a risk assessment was carried out at all the affected surgeries and has concluded that the effectiveness of the stored vaccines had not been "significantly compromised" and revaccination was not "clinically indicated".

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But an expert said it may make the vaccines less likely to be effective, and politicians and patients' groups said the report raised serious questions.

The audit was launched after four scares in 2007 involving over 1,000 patients who had to be revaccinated when it emerged the jabs they had received had not been stored correctly. The snapshot audit figures are from 2007.

Every year, staff at surgeries immunise around 100,000 children against a number of illnesses including measles, mumps, rubella, tetanus, meningitis, polio and diphtheria. Vaccines have a shelf life of around two years, but many are designed to give lifelong immunity.

The audit ordered by the Scottish Government Health Department found that out of 1,030 GP practices, a total of 503 were not fully compliant with regulations on storing vaccines during a three-month period. Of those, 148 were not storing their vaccines in accordance with manufacturers' instructions.

They were in six health boards: Ayrshire and Arran, Forth Valley, Grampian, Glasgow and Clyde, Highland, and Tayside. Only two boards, NHS Borders and NHS Shetland, reported no problems with vaccine storage. The report said: "Inappropriate vaccine storage is very serious and has the potential to present a public health problem and constitute a risk to patient safety."

It went on to say that a risk assessment was carried out in the 148 cases where vaccines were not being stored correctly. It concluded that the "duration or degree of non-compliance was assessed as insufficient to have significantly compromised the effectiveness of the stored vaccine" and ruled out revaccinating patients as this is only carried out where there is an "extreme departure from storage instructions".

Factors such as temperature, exposure to light and shelf life can be crucial to the effectiveness of a vaccine. Many were being stored in domestic fridges which experts say are not always fit for the job. But an expert warned that even if the vaccines were not judged to be damaged enough to be thrown out, they may not be 100 per cent effective.

Dr David Cavanagh, an expert in vaccines at the Institute of Immunology and Infection Research at Edinburgh University, said of the report: "That does not sound great, and is of concern. We have measles back in the UK, which is to do with the MMR uptake, and the implications of not storing vaccines correctly are much the same. If you give it to 100 per cent of people but 30 per cent of the vaccines are knackered because they were not stored in the correct conditions, you effectively have the same problem.

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"Sometimes the wrong temperature would make a live vaccine degrade. If you store it for three months it may lose 10 per cent of its activity but still be acceptable. But that would depend on temperature, and if it is rising and falling, particularly below zero, that's not good for live vaccines.

"One of the problems could be that people don't have high-enough specification fridges. Fridges and freezers also break down a lot. Domestic fridges are of variable quality and a lot have a frost-free facility that stops them from icing up, by raising the temperature in a cycling system to melt the ice. Unstable temperature storage would always adversely affect vaccines," he added.

"It means people may not make a good response to the vaccine, and it may leave people open to infection when they shouldn't be. In terms of routine food storage it makes little difference, but it's not a great idea for vaccines."

The investigation was sparked after problems were found at four surgeries which had faulty fridges, meaning the vaccines were rendered ineffective by being stored at the wrong temperatures.

Vaccines are supposed to be kept at temperatures between 2-8C in order to protect the live component that provides protection. Staff are required to monitor fridge temperatures each working day. In 2007, a total of 1,023 adults and children had to be revaccinated in Forth Valley and Grampian after investigations found faulty fridges were causing vaccines to freeze and defrost.

Following the disclosure, the Scottish Government ordered health boards to request the last three months' temperature readings from each of their GP practices. The results were published yesterday.

Labour health spokesman Richard Simpson warned the issue raised serious questions about safe storage of the swine flu vaccine. He said: "As we prepare to go into a potential pandemic, it's crucial that health boards ensure fridges are compliant and systems are adequate. The question is whether people who have been vaccinated are actually immune, or whether we have been given a false sense of security."

Scottish Conservative health spokeswoman Mary Scanlon said: "This is quite shocking. Due to the uncertainty it's impossible to estimate how many people should be revaccinated. This could also scupper the seasonal and swine flu vaccination campaign if there are storage issues."

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Dr Dean Marshall, chairman of the British Medical Association's GP committee, said: "Practices have to look at their own systems and make sure they are totally compliant. Guidance is updated regularly and I would expect most practices would have updated their systems by now."

A Scottish Government spokeswoman last night said improvements have now been made to the system. She added: "In the vast majority of instances where practices did not completely comply with regulations these related to minor issues involving monitoring and logging fridge temperatures. The vaccines were not compromised. Revaccination is only considered where the effectiveness of the vaccine could have been compromised. This involved only four of the 1,030 practices surveyed."

How effective are vaccines?

Most licensed vaccines are not 100% effective in everyone who receives them. This is because many factors affect the immune system and its ability to respond to the antigen in the vaccine.

For example, the flu jab is about 70 per cent effective, the DTP vaccine is 95 per cent effective and the first dose of the MMR vaccine is about 95-99 per cent effective, although its overall effectiveness improves once the child has had the booster jab.

Some vaccines also last longer than others. For example, the tetanus jab is effective for ten years, while inoculations against measles, mumps and rubella are expected to last a lifetime.

The fact vaccines do not work 100 per cent in everyone who receives them is why population-based vaccination programmes rely on vast proportions of the target populations coming forward.

It means if large enough numbers have received the inoculation, "herd immunity" is achieved, which means that so many people are immune they help protect the people who aren't.